(382 days)
Not Found
No
The device description focuses on the physical and chemical properties of a hydrogel dressing and does not mention any computational or analytical capabilities.
Yes.
The device is intended for OTC use on wounds such as minor cuts, grazes, scalds, burns, and insect bites, and is designed to provide a moist healing environment and antiseptic barrier protection, which are characteristics of a therapeutic device.
No
The device is a dressing intended for OTC use on wounds, providing antiseptic barrier protection and a moist healing environment. Its function is to treat wounds, not to diagnose medical conditions.
No
The device description clearly describes a physical dressing with hydrogel and adhesive film, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for treating wounds topically (minor cuts, grazes, burns, insect bites). This is a direct application to the body for therapeutic purposes.
- Device Description: The description details a wound dressing with an antiseptic hydrogel. This is a physical barrier and treatment applied externally.
- Lack of In Vitro Testing: There is no mention of the device being used to test samples in vitro (outside the body) to diagnose a condition or provide information about a physiological state. The performance studies focus on biocompatibility and antiseptic barrier activity, which are relevant to a topical wound dressing.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
These dressings are intended for OTC use on wounds such as:
- Minor cuts and grazes .
- Minor scalds and burns .
- Insect bites .
MedTrade Products Antiseptic Barrier Hydrogel Dressings are contraindicated for:
- . Third degree burns
Product codes
MGQ
Device Description
MedTrade Product's Antiseptic Barrier Hydrogel Dressings consist of an Antiseptic Hydrogel, which is over 70% pure water. Effective antiseptic barrier protection of the dressing against microbes and microbial contamination is provided by the antiseptic barrier hydrogel and adhesive film cover of the dressing is made from a special Antiseptic Barrier hydrogel formulation which not only has a high water activity (a measure of cooling) but is also capable of absorbing substantial quantities of fluid. This makes it especially suitable for use on burns with minimal risk of maceration. The Antiseptic Barrier hydrogel dressings are highly conformable, soft, absorbent, sterile, primary wound dressings of a gelatinous mass which provides a moist healing environment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
OTC use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatability testing including: Dermal Irritation, Dermal Sensitization, Cytotoxicity, Acute Systemic Toxicity and Hemocompatibility/Hemolysis have been successfully completed per ISO/Tripartite guidelines. Additionally, MedTrade Products Antiseptic Barrier Hydrogel has been shown to have "Antiseptic Barrier activity".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
AUG 2 2 2003
510k Summary
K022587
H. Safety & Effectiveness: MedTrade Product's Antiseptic Barrier Hydrogel Dressings Classification Name: NAE 878.4022 Bandage Liquid
Contact: Jonathan Ranfield, Director of Quality Assurance & Regulatory Affairs
MedTrade Products Ltd, Electra House, Crewe Business Park, Crewe, CW1 6GL. UK. Tel: +44 (0) 1270 500019. Fax: +44 (0) 1270 500045
Prepared: August 10, 2002
Description: MedTrade Product's Antiseptic Barrier Hydrogel Dressings consist of an Antiseptic Hydrogel, which is over 70% pure water. Effective antiseptic barrier protection of the dressing against microbes and microbial contamination is provided by the antiseptic barrier hydrogel and adhesive film cover of the dressing is made from a special Antiseptic Barrier hydrogel formulation which not only has a high water activity (a measure of cooling) but is also capable of absorbing substantial quantities of fluid. This makes it especially suitable for use on burns with minimal risk of maceration. The Antiseptic Barrier hydrogel dressings are highly conformable, soft, absorbent, sterile, primary wound dressings of a gelatinous mass which provides a moist healing environment.
MedTrade Product's Antiseptic Barrier Hydrogel Dressings are indicated for OTC use on minor cuts & grazes, minor scalds & burns and insect bites. If at any time you are unsure of the above conditions or type of wound consult a health care professional.
Dressings are supplied sterile in single use pouches. Product is gamma irradiated in accordance with the Sterilisation of Health Care Products - Requirements for Validation and Routine Control - Radiation Sterilisation, 300 Edition (ANS/AAMI/ISO11137 - 1995) and Microbiological Methods for Gamma Sterilisation (AAMI TIR8-1991) for qualification for Method 1 for dosimetric release with a sterility assurance level of 10 -Biocompatability testing including: Dermal Irritation, Dermal Sensitization, Cytotoxicity, Acute Systemic Toxicity and Hemocompatibility/Hemolysis have been successfully completed per ISO/Tripartite guidelines.
MedTrade Product's Antiseptic Barrier Hydrogel Dressings are substantially equivalent in design, composition and function to MedTrade Product's Hydrogel Island Dressings K002504, with the addition of an antiseptic, to provide an antiseptic barrier hydrogel. A table of comparative features may be found below.
| Characteristics | MedTrade Product's
Hydrogel Island Dressing
Exempted 510(k) K002504 | MedTrade Product's
Antiseptic Barrier Hydrogel
Island Dressing |
|------------------------|---------------------------------------------------------------------------|----------------------------------------------------------------------|
| Hydrogel - Composition | High water content medical
grade hydrophilic polymer | High water content medical
grade hydrophilic polymer |
| Backing | Self Adhesive Film | Self Adhesive Film |
| Adhesive | Medical grade pressure
sensitive adhesive | Medical grade pressure sensitive
adhesive |
| Adhesive Coverage | 100% on backing | 100% on backing |
| Indications For Use | Minor cuts & grazes
Minor scalds & burns
Insect Bites | Minor cuts & grazes
Minor scalds & burns
Insect Bites |
| Packaging | Printed Pouch | Printed Pouch |
| Supplied | Sterile | Sterile |
ATIVE
Additionally, MedTrade Products Antiseptic Barrier Hydrogel has been shown to have "Antiseptic Barrier activity".
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the image.
AUG 22 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jonathan Ranfield Director, Quality Assurance & Regulatory Affairs MedTrade Products Ltd. Electra House Crewe Business Park Crewe, Cheshire United Kingdom CW1 6GL
Re: K022587
Trade/Device Name: MedTrade Product's Antiseptic Barrier Hydrogel Dressings Regulatory Class: Unclassified Product Code: MGQ Dated: June 18, 2003 Received: June 20, 2003
Dear Mr. Ranfield:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Mr. Jonathan Ranfield
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Mark N Wilkerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of 1
510(k) Number (if known) . KO22587 ............................................................................................
Device Name: MedTrade Product's Antiseptic Barrier Hydrogel Dressings
These dressings are intended for OTC use on wounds such as:
- Minor cuts and grazes .
- Minor scalds and burns .
- Insect bites .
MedTrade Products Antiseptic Barrier Hydrogel Dressings are contraindicated for:
- . Third degree burns
The components do not contain animal ingredients.
(PLEASE DO NOT WRITE BELOW THIS LINE, CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801.190) | Or | Over The Counter Use | X | (Optional Format 1-2-96) |
|---|---|---|---|---|
| ------------------------------------------ | ---- | ---------------------- | --- | -------------------------- |
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
| 510(k) Number | K022587 |
|---|---|
| --------------- | --------- |